FDA.reportPublic FDA data

Hydromorphone Hydrochloride

Product NDC
63629-4284
11-digit product format
636294284
Labeler code
63629
Product ID
63629-4284_07884a78-2a01-453c-870b-7b757b530d22
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydromorphone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA019892
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2009-11-23
Substance
HYDROMORPHONE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydromorphone Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROMORPHONE HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL960UP2KRW
Rxcui897696

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c92985da-a658-b186-e763-2287eda87a86Product name320250221
96c475b3-58c7-b955-d715-0111804a3e50Product name520210512
1dd54659-b775-4fa8-a858-7f0e521fbadcProduct name420200925

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-4284-1Hydromorphone Hydrochloride25 in 1 BOTTLETABLET2519
63629-4284-2Hydromorphone Hydrochloride60 in 1 BOTTLETABLET6019
63629-4284-3Hydromorphone Hydrochloride30 in 1 BOTTLETABLET3019
63629-4284-4Hydromorphone Hydrochloride28 in 1 BOTTLETABLET2819
63629-4284-5Hydromorphone Hydrochloride90 in 1 BOTTLETABLET9019
63629-4284-6Hydromorphone Hydrochloride120 in 1 BOTTLETABLET12019
63629-4284-7Hydromorphone Hydrochloride40 in 1 BOTTLETABLET4019
63629-4284-8Hydromorphone Hydrochloride20 in 1 BOTTLETABLET2019
63629-4284-9Hydromorphone Hydrochloride10 in 1 BOTTLETABLET1019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-4284-1EA - Each63629-4284fb91d1e2-a329-4b55-a47f-4c56fe07857b12012-07-24
63629-4284-2EA - Each63629-42840742eef8-2ff9-4578-9ff1-7bef31b241f512012-07-24
63629-4284-3EA - Each63629-428486f4f302-9883-4ce8-a9a5-265caab15c4312012-07-24
63629-4284-4EA - Each63629-428429cb51f9-d072-4102-9c57-e8fd1f15ee9a12012-07-24
63629-4284-5EA - Each63629-428411bb868f-5035-4266-8a2c-6444c3f3a16112012-07-24
63629-4284-6EA - Each63629-4284e37026f1-eb59-42ff-87ac-cbd65d7958d812012-07-24
63629-4284-7EA - Each63629-4284ee0b5735-d3d2-4f63-a7fc-fcb4cf88341d12015-10-02
63629-4284-9EA - Each63629-4284668e7bf2-db7d-4acb-b0de-b99e90bf914712024-02-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROMORPHONE HYDROCHLORIDEACTIVE INGREDIENTL960UP2KRWHYDROMORPHONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]2
HYDROMORPHONEACTIVE MOIETYQ812464R06HYDROMORPHONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]2
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BHYDROMORPHONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROMORPHONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GHYDROMORPHONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROMORPHONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]2
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CHYDROMORPHONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4284HYDROMORPHONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]19Current NDC, Legacy NDC, 9 package rows20250412_2427814c-f32b-8ac5-99b8-5e886fd2d001.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897696HYDROmorphone HCl 2 MG Oral TabletPSN2427814c-f32b-8ac5-99b8-5e886fd2d00119
897696hydromorphone hydrochloride 2 MG Oral TabletSCD2427814c-f32b-8ac5-99b8-5e886fd2d00119

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-4284-16362942840125 TABLET in 1 BOTTLE (63629-4284-1) 25 tablet2010-06-210000-00-00NoNoCurrent
63629-4284-26362942840260 TABLET in 1 BOTTLE (63629-4284-2) 60 tablet2011-08-230000-00-00NoNoCurrent
63629-4284-36362942840330 TABLET in 1 BOTTLE (63629-4284-3) 30 tablet2010-10-220000-00-00NoNoCurrent
63629-4284-46362942840428 TABLET in 1 BOTTLE (63629-4284-4) 28 tablet2010-11-120000-00-00NoNoCurrent
63629-4284-56362942840590 TABLET in 1 BOTTLE (63629-4284-5) 90 tablet2014-06-110000-00-00NoNoCurrent
63629-4284-663629428406120 TABLET in 1 BOTTLE (63629-4284-6) 120 tablet2012-06-250000-00-00NoNoCurrent
63629-4284-76362942840740 TABLET in 1 BOTTLE (63629-4284-7) 40 tablet2014-01-270000-00-00NoNoCurrent
63629-4284-86362942840820 TABLET in 1 BOTTLE (63629-4284-8) 20 tablet2012-05-010000-00-00NoNoCurrent
63629-4284-96362942840910 TABLET in 1 BOTTLE (63629-4284-9) 10 tablet2020-08-240000-00-00NoNoCurrent